Bladder instillation of Botox with iontophoresis for overactive bladder - a pilot study

Pilot study to evaluate the effect of instillation treatment with onabotulinumtoxin A (BOTOX®) in the urinary bladder using Electromotive Drug Application (EMDA) in women with overactive bladder.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-001680-40-NO

Enrollment

Registered

2016-05-11

Start date

2016-05-10

Completion date

Unknown

Last updated

2025-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overactive bladder

Interventions

Trade Name: Botox Product Name: Botox Pharmaceutical Form: Powder for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • OAB/urgency incontinence of at least 3 months duration • Conservative treatment (medicines, electrical stimulation) has been tried without sufficient benefit • There is indication for injection treatment with Botox® • More than 3months since any previous treatment with Botox® Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: • Mixed incontinence with predominant stress component • Age below 18 years • Insuffcient understanding of Norwegian and / or unable to fill out the necessary forms • Ongoing urinary tract infection

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective of the trial is to see if instillation of BOTOX® into urinary bladder using iontophoresis proves to have sufficient effect on patient symptoms without significant side effects;Secondary Objective: Not applicable;Primary end point(s): - Scores on the following questionnaires: UDI-6, IIQ-7, ICIQ-UI SF. - Number of voids and mean voided volume on a 24-hour voiding chart - 24-hour leakage in grams;Timepoint(s) of evaluation of this end point: - Scores on the questionnaires: at 2 weeks, 4 weeks, 3 months, 6 months - Number of voids and mean voided volume on a 24-hour voiding chart: at 2 weeks, 4 weeks, 3 months, 6 months - 24-hour leakage in grams: at 4 weeks, 3 months, 6 months	—

Measure

Time frame

Main Objective: The objective of the trial is to see if instillation of BOTOX® into urinary bladder using iontophoresis proves to have sufficient effect on patient symptoms without significant side effects;Secondary Objective: Not applicable;Primary end point(s): - Scores on the following questionnaires: UDI-6, IIQ-7, ICIQ-UI SF. - Number of voids and mean voided volume on a 24-hour voiding chart - 24-hour leakage in grams;Timepoint(s) of evaluation of this end point: - Scores on the questionnaires: at 2 weeks, 4 weeks, 3 months, 6 months - Number of voids and mean voided volume on a 24-hour voiding chart: at 2 weeks, 4 weeks, 3 months, 6 months - 24-hour leakage in grams: at 4 weeks, 3 months, 6 months

—

Secondary

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Norway

Contacts

Public ContactHjalmar Schiotz

Vestfold Hospital

hjalmar.schiotz@siv.no4733342000

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026